MASTERGRAFT® STRIP
GUDID 00613994407801
STRIP 7800320 MASTERGRAFT STRIP 20CM
MEDTRONIC SOFAMOR DANEK, INC.
Bone matrix implant, animal-derived, bioabsorbable| Primary Device ID | 00613994407801 |
| NIH Device Record Key | 4559833f-586a-4402-84e5-d8d764f18161 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MASTERGRAFT® STRIP |
| Version Model Number | 7800320 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
| Width | 2 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994407801 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082166
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-07-20 |
On-Brand Devices [MASTERGRAFT® STRIP]
| 00613994487339 | STRIP 7800336 MASTERGRAFT 36 CM |
| 00613994407818 | STRIP 7800310 MASTERGRAFT STRIP 10CM |
| 00613994407801 | STRIP 7800320 MASTERGRAFT STRIP 20CM |
| 00643169719385 | STRIP 7800336 MASTERGRAFT STRIP 36CM |
| 00643169719378 | STRIP 7800320 MASTERGRAFT STRIP 20CM |
| 00643169719361 | STRIP 7800310 MASTERGRAFT STRIP 10CM |
| 00643169486485 | STRIP 7800336 MASTERGRAFT 36 CM |
| 00643169486478 | STRIP 7800320 MASTERGRAFT STRIP 20CM |
| 00643169486461 | STRIP 7800310 MASTERGRAFT STRIP 10CM |
Trademark Results [MASTERGRAFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MASTERGRAFT 78112930 2921419 Live/Registered |
MEDTRONIC SOFAMOR DANEK USA, INC. 2002-03-06 |
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